Omakyn
Vynix LLC
Affordable, fixed-price FDA cybersecurity gap analysis for medical device makers. Get an instant, free readiness snapshot and transparent pricing for submission-ready documentation.
About
**Who they are**
Omakyn provides automated FDA cybersecurity compliance solutions for medical device manufacturers. They focus on delivering rapid, actionable insights to help companies navigate complex regulatory requirements.
**Expertise & scope**
* Analyzes medical devices against all 9 compliance areas of FDA's cybersecurity and AI/ML guidance.
* Delivers prioritized gap reports in minutes.
* Offers a free, instant readiness snapshot.
* Provides transparent pricing for submission-ready documentation.
* Focuses on identifying vulnerabilities before FDA reviewers do.
* Generates SBOMs in CycloneDX format with CVE cross-references.
**Reputation / proof points**
* The FDA's current cybersecurity guidance (Feb 2026) makes cybersecurity compliance mandatory for every connected medical device.
Omakyn provides automated FDA cybersecurity compliance solutions for medical device manufacturers. They focus on delivering rapid, actionable insights to help companies navigate complex regulatory requirements.
**Expertise & scope**
* Analyzes medical devices against all 9 compliance areas of FDA's cybersecurity and AI/ML guidance.
* Delivers prioritized gap reports in minutes.
* Offers a free, instant readiness snapshot.
* Provides transparent pricing for submission-ready documentation.
* Focuses on identifying vulnerabilities before FDA reviewers do.
* Generates SBOMs in CycloneDX format with CVE cross-references.
**Reputation / proof points**
* The FDA's current cybersecurity guidance (Feb 2026) makes cybersecurity compliance mandatory for every connected medical device.
Additional information
Omakyn's service is designed for speed and efficiency, allowing medical device makers to obtain a cybersecurity gap report in under 5 minutes by answering 18 questions. This automated approach aims to prevent costly delays and remediation efforts that often arise during the FDA review process. The platform analyzes devices across nine key compliance areas outlined in the FDA's cybersecurity and AI/ML guidance, providing a prioritized report to help teams understand their current standing and next steps. This is particularly beneficial for companies just beginning to consider FDA cybersecurity for their devices or those wanting to assess their readiness before committing to a submission timeline.
Key Highlights
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Offers a free, instant readiness snapshot for FDA cybersecurity.
Source
“Get an instant, free readiness snapshot”
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Provides a prioritized gap report in minutes, not months.
Source
“delivers a prioritized gap report in minutes — not months.”
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Analyzes devices across all 9 compliance areas of FDA’s cybersecurity and AI/ML guidance.
Source
“analyzes your medical device across all 9 compliance areas of the FDA’s cybersecurity and AI/ML guidance”
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Generates SBOMs in CycloneDX format with CVE cross-references.
Source
“SBOM in CycloneDX format with CVE cross-references — known before filing”
Certifications & Trust Signals
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The FDA's current cybersecurity guidance (Feb 2026) makes cybersecurity compliance mandatory for every connected medical device.
Source
“The FDA's current cybersecurity guidance (Feb 2026) makes cybersecurity compliance mandatory for every connected medical device.”
Buyer Snapshot
Best for
- Medical device makers needing rapid FDA cybersecurity gap analysis.
- Companies seeking to identify compliance gaps before FDA review.
- Organizations requiring submission-ready documentation.
How engagement typically works
- Automated, self-service analysis.
- Instant report generation.
- Transparent pricing.
Typical deliverables
- Prioritized FDA cybersecurity gap report.
- Readiness snapshot.
- SBOM in CycloneDX format with CVE cross-references.
Good to know
- Best when needing to quickly assess cybersecurity compliance for connected medical devices.
Pricing
Model:
Per project
Public range:
Publicly listed: $2 - $4,997
Notes:
Based on publicly listed information; final fees depend on scope.
“$8.9; $2; $1,497; $4,997; $50”
Facts
Examples & Achievements
- Free FDA 524B Gap Analyzer — instant readiness snapshot, no sales call required
- Transparent fixed pricing — see the price before you commit, no custom quotes
- Focused 524B scope: gap analysis + threat modeling + submission-ready docs
- Clear timelines - Readiness Review 10 business days, Submission Package 4-6 weeks
- Built for small & early-stage manufacturers and their RA/QA consultants
- 100% remote, US FDA-focused
- Transparent fixed pricing — see the price before you commit, no custom quotes
- Focused 524B scope: gap analysis + threat modeling + submission-ready docs
- Clear timelines - Readiness Review 10 business days, Submission Package 4-6 weeks
- Built for small & early-stage manufacturers and their RA/QA consultants
- 100% remote, US FDA-focused
More about our services
Our services are designed for clarity and speed:
**Services:**
* **FDA 524B Cybersecurity Gap Analyzer:** A free, instant online tool to get a snapshot of your readiness.
* **Readiness Review — $4,900:** Where you stand today. A prioritized gap report against the FDA premarket guidance, an assessment of each artifact you already have, the deficiencies you would likely get if you filed as-is, and a recommended remediation sequence. Does not produce documents.
* **Submission Package — $14,900:** Your cybersecurity documentation, written. STRIDE threat model, security risk assessment based on exploitability, security architecture views, SBOM review (CycloneDX/SPDX) with end-of-support analysis, post-market vulnerability management plan, and cybersecurity labeling in eSTAR-formatted sections. Two rounds of revision.
**What we do not do:** penetration and vulnerability testing (FDA requires the testing evidence, so you will need a testing provider), SBOM generation, source code review, implementing the remediation, full regulatory strategy, and final sign-off. If you have an SBOM, we review it against what FDA expects. Producing one from your build is a different job.
**Also selling into the EU?** The Cyber Resilience Act already has wearables in scope, with vulnerability reporting obligations starting 11 September 2026. Free CRA readiness check at omakyn.com/cra.
**Onboarding Process:**
1. Start with the free online Gap Analyzer.
2. Book a fixed-price service directly. No sales call.
3. Securely provide device and architecture documentation for kickoff.
4. Receive your report plus a recorded 15-minute video walkthrough.
5. Email Q and A support while your support window is open.
**Services:**
* **FDA 524B Cybersecurity Gap Analyzer:** A free, instant online tool to get a snapshot of your readiness.
* **Readiness Review — $4,900:** Where you stand today. A prioritized gap report against the FDA premarket guidance, an assessment of each artifact you already have, the deficiencies you would likely get if you filed as-is, and a recommended remediation sequence. Does not produce documents.
* **Submission Package — $14,900:** Your cybersecurity documentation, written. STRIDE threat model, security risk assessment based on exploitability, security architecture views, SBOM review (CycloneDX/SPDX) with end-of-support analysis, post-market vulnerability management plan, and cybersecurity labeling in eSTAR-formatted sections. Two rounds of revision.
**What we do not do:** penetration and vulnerability testing (FDA requires the testing evidence, so you will need a testing provider), SBOM generation, source code review, implementing the remediation, full regulatory strategy, and final sign-off. If you have an SBOM, we review it against what FDA expects. Producing one from your build is a different job.
**Also selling into the EU?** The Cyber Resilience Act already has wearables in scope, with vulnerability reporting obligations starting 11 September 2026. Free CRA readiness check at omakyn.com/cra.
**Onboarding Process:**
1. Start with the free online Gap Analyzer.
2. Book a fixed-price service directly. No sales call.
3. Securely provide device and architecture documentation for kickoff.
4. Receive your report plus a recorded 15-minute video walkthrough.
5. Email Q and A support while your support window is open.
HQ:
Sheridan, US
Languages:
English, Spanish
Timezones:
America/Denver
Claim status:
Claimed
Services & Capabilities
Medical Device Cybersecurity
Jurisdictions:
US, EU
Industries:
Medical Devices
Portfolio:
1-5, 6-25
Flags:
fast_onboarding
Response SLA:
24 hours
Onboarding time:
1–3 days
Pricing model:
Per project
Starting from:
USD 4,900
Included services:
FDA 524B gap analysis, Prioritized remediation list, Submission-ready documentation, SBOM Review, STRIDE threat modeling
Provider Type:
Both
Service Categories:
Threat Modeling & Risk Analysis
Submission Stage Support:
Pre-Submission (Planning), Ready for 510(k)/MDR Submission
Device Types Supported:
Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
Standards Frameworks:
FDA Section 524B, NIST Cybersecurity Framework, EU Cyber Resilience Act
Pen Testing Available:
No
Threat Modeling Available:
Yes
Sbom Management Available:
No
Vulnerability Monitoring Available:
No
Rta Rescue Available:
No
